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Capabilities / Life Sciences

Life Sciences

Smart legal answers as our clients discover, develop, and commercialize advancements in the life sciences.

Our Life Sciences team counsels companies industrywide, from emerging growth ventures and research-driven startups to established public companies, strategic investors, and industry participants operating on a scale. We represent pharmaceutical, biotechnology, medical device, and digital health clients in matters spanning the full business and product life cycle—from formation, financing, licensing, and clinical development to intellectual property strategy and litigation, regulatory compliance, disputes, and strategic transactions. Rather than approaching life sciences issues in isolation, we deliver coordinated, business-minded counsel calibrated to the scientific, operational, and commercial realities our clients face.

With more than 150 healthcare and life sciences attorneys across the firm, we bring a broad understanding of the regulatory, reimbursement, operational, and transactional issues that shape the healthcare marketplace. We pair that substantive depth with practical staffing models, competitive rate structures, and thoughtful alternative fee approaches designed to align with clients’ business objectives.

Life Sciences Litigation

We represent life sciences clients in high-stakes life sciences disputes where intellectual property, market position, and enterprise value are on the line. Our litigators have extensive experience handling patent infringement actions—including litigation arising under the Hatch-Waxman Act and BPCIA—post-grant proceedings, ITC matters, and related intellectual property disputes. Our life sciences litigators have extensive experience with all phases of litigation, including pre-trial work, injunction proceedings, Markman hearings, trials, and appeals.

Life Sciences Due Diligence

We help life sciences clients evaluate risk, determine and validate value, and make informed decisions at critical moments consistent with their life sciences business objectives. Whether buy-side or sell-side, our team conducts strategic due diligence and pre-dispute assessments designed to pressure-test key assets, identify vulnerabilities, and uncover opportunities across patent portfolios and related intellectual property positions. We deliver practical insight and technical expertise that ensures our clients act with confidence and clarity—whether determining patentability or freedom-to-operate, shaping litigation strategy, planning transactions such as mergers and acquisitions, or making broader business decisions.

Life Sciences Patent Prosecution

We counsel companies, universities, research institutions, and innovators on patent preparation, prosecution, and portfolio development for life sciences assets. Early in the innovation cycle and often in close collaboration with our due diligence teams, our patent attorneys conduct patentability assessments and freedom-to-operate analyses so clients can make informed decisions about protection strategy, product development, and market entry. Our advice addresses not only patent scope and validity considerations, but also practical issues such as privilege, confidentiality, and alternative paths for mitigating risk.

Our patent attorneys regularly represent clients before the U.S. Patent and Trademark Office, including in appeals before the Patent Trial and Appeal Board. Drawing on deep technical fluency and sector experience, our team of patent attorneys and other professionals with technical backgrounds helps clients build, manage, and enforce patent portfolios that protect innovation, support commercial objectives, and create long-term enterprise value.

Life Sciences Transactions and Licensing

Life sciences companies turn to us for transactional counsel that reflects the realities of their industry. We advise innovators, investors, and research institutions on deals where corporate, intellectual property, and regulatory issues are deeply intertwined, including strategic collaborations, licensing arrangements, material transfer agreements, IP acquisitions or divestitures, company or business line acquisitions or divestitures, and growth financings. By engaging early, we help clients structure transactions that support commercialization, preserve value, and position the business for what comes next.

Husch Blackwell works closely with in-house legal and business teams to navigate the operational and commercial issues that shape life sciences transactions, including governance and control rights, buyout structures, operating arrangements, and payor-related considerations. Where needed, we also coordinate with internal stakeholders on broader communication and positioning strategies to support successful execution.

Life Sciences Regulatory Compliance

Our life sciences regulatory attorneys, many with backgrounds in scientific research, advise on the legal and regulatory frameworks that govern product development, commercialization, technology licensing, and clinical research. We assist clients from early-stage development through approval and post-market compliance, and we regularly counsel on the privacy and data governance issues that arise in digital health, connected care, and telehealth models.

We also advise on Food and Drug Administration requirements affecting medical devices, pharmaceuticals, biotechnology products, and radiation-emitting electronic products, including enforcement and compliance matters when issues arise. Our Life Sciences practice further includes a Psychedelics & Emerging Therapies team focused on the legal and regulatory questions presented by this evolving area of drug development.

Life Sciences Product Liability Defense

Husch Blackwell defends pharmaceutical, biotechnology, medical device, diagnostic, and consumer health companies in high-stakes product liability matters arising across the life sciences product lifecycle, from clinical development and regulatory approval through manufacturing, marketing, and post-market use. We develop strategies for single-incident cases, mass torts, and multidistrict litigation involving alleged design and manufacturing defects, failures to warn, adverse events, and complex questions of causation. As national and regional coordinating counsel, we align discovery, scientific and regulatory evidence, trial strategy, and local counsel across jurisdictions. Our attorneys collaborate with leading toxicologists, epidemiologists, engineers, scientists, and medical professionals to address technical issues involving product safety, efficacy, labeling, and risk. Drawing on experience with pharmaceuticals, biologics, diagnostics, dietary supplements, genetically modified seeds, surgical implants, and medical equipment, we help clients protect patients, preserve enterprise value, and manage litigation efficiently throughout commercialization.

Life Sciences Artificial Intelligence

As artificial intelligence (AI) reshapes the life sciences industry, from AI-enabled diagnostics and drug discovery to digital health platforms and connected medical devices, companies must navigate an increasingly complex and rapidly evolving state and federal legal and regulatory landscape. Husch Blackwell’s Life Sciences team provides strategic counsel on critical matters, including intellectual property risks associated with AI adoption, patent protection and prosecution for AI-driven innovations, and the negotiation and drafting of AI vendor agreements, licensing arrangements, and technology procurement contracts.

Life Sciences Real Estate

Husch Blackwell’s Real Estate, Development & Construction team is equipped to address the specialized demands of life sciences real estate by combining broad national resources with experience across development, construction, financing, land use, tax incentives, contracting, and litigation. This multidisciplinary capability enables the team to align sophisticated facilities, including laboratories, research campuses, and manufacturing sites with clients’ scientific operations, regulatory obligations, infrastructure requirements, and commercialization strategies.

Life Sciences Bankruptcy and Insolvency

Husch Blackwell combines restructuring experience with deep life sciences industry knowledge. Our multidisciplinary team helps clients protect critical assets, preserve value, and pursue strategic alternatives while advancing regulatory, research, and commercialization priorities.

Life Sciences Clinical Trials

Husch Blackwell guides life sciences companies through the full clinical trial lifecycle, from study planning and trial operations to research agreements, participant data privacy, HIPAA compliance, provider and site arrangements, reimbursement, specialty pharmacy, and intellectual property strategy. By integrating scientific, regulatory, operational, and commercial insight, we help clients structure and conduct clinical research, manage risk, protect innovation, and move promising therapies and technologies toward approval and commercialization.

Life Sciences Immigration

Our Life Sciences and Immigration teams work together to respond to clients’ workforce needs, helping them recruit and retain the specialized foreign talent essential to research, clinical development, manufacturing, and commercialization. We develop practical sponsorship and compliance strategies that support workforce continuity, growth, and innovation.

Life Sciences Manufacturing and Supply Chain

Our Life Sciences and International Trade & Supply Chain teams work together to help clients build resilient global operations, move critical products and materials across borders, and respond to evolving trade requirements. We provide coordinated guidance on tariffs, import and export compliance, enforcement, supply chain risk, and complex trade strategies to help clients protect continuity, manage disruption, and advance growth.

Representative Experience

Regulatory

  • Researched and drafted briefing on federal preemption issues on behalf of leading global medical device manufacturer surrounding pharmaceutical and healthcare products.
  • Advised higher education client on federal regulations and California law governing who is able to prescribe, administer and dispense controlled substances under California law, information needed for DEA licensing requirements, and clinic licensing requirements for human studies involving psychedelic substances.
  • Advised business on current state and federal drug paraphernalia laws and liability issues related to psychedelic substances.
  • Advised venture capital firm as to liability risks associated with proposals that could implicate international treaties on psychedelics.
  • Advised author as to liability issues related to contract with publisher and drafted disclaimer language for author's book related to psychedelic-assisted therapy.
  • Provided advisory services related to developing a ketamine clinical network.
  • Prepared informed consent documents to comply with healthcare regulations for therapy practice utilizing new technology.
  • Represented healthcare practitioner to negotiate and resolve claims associated with a therapeutic instrument.
  • Provided analysis of company drug discovery regulatory files in order to provide a due diligence evaluation that would enable potential investors to understand potential risks involved that could impact the business.
  • Assist clients with digital health software matters, including requirements for design controls, mobile medical apps, exemptions for medical software, and compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act.
  • Created and implemented an administrative review process for human research studies for a large health system, including development of related policies and procedures.
  • Advised clinical trial and institutional review boards (IRBs) on compliance matters.
  • Organized and supervised clinical trials for early-stage biotechnology company.
  • Led top-to-bottom review and enhancement of medical device manufacturer’s compliance program, including clinical trials and investigation policies, procedures, and implementation.
  • Drafted and negotiated clinical trial agreements with principal investigators, institutions, sponsors, SMOs, and CROs.
  • Drafted and negotiated royalty agreements between manufacturers and physicians.
  • Assisted preeminent research facility with the development of COVID testing innovation and research strategy, including analysis of FDA, EUA, laboratory developed tests, and PREP Act implications and community outreach contracts.
  • Advised national laboratory on licensing, CLIA, and FDA regulatory issues related to COVID-19 screening and surveillance procedures using its FDA-authorized diagnostic test, and analyzed impact on PREP Act immunity.
  • Assisted in the conversion of an animal laboratory to a human laboratory in the areas of CLIA, licensure, privacy, and billing matters.
  • Helped evaluate compliance with federal research regulations (informed consent/IRB issues), National Institutes of Health Grants Policy Statement (NIHGPS), and related federal regulations and investigations in area of pediatric and adult research.
  • Assisted in the sale of a nutrigenomic laboratory to provide healthcare regulatory due diligence guidance to minimize risk.

Litigation

  • Represented TWi Pharmaceuticals in connection with its development and marketing of a generic version of cladribine successfully invalidating all relevant claims of the patents on multiple sclerosis drug Mavenclad® before the Patent Trials and Appeals Board, decisions affirmed by the Federal Circuit. Merck Serono S.A. v. TWi Pharmaceuticals, Inc. (D. Del 2026).
  • Successfully represented the complainant, Ventria Bioscience Inc., in Certain Plant-Derived Recombinant Human Serum Albumins & Products Containing Same, Inv. No. 337-TA-1238, a case involving patent infringement and false designation of origin against a Wuhan, China-based competitor (a company founded by a former employee of Ventria) and its U.S. distributors. The case went to trial in November 2021. In September 2022, the ITC found all respondents in violation of Section 337 and issued remedial orders that exclude the infringing and mislabeled products from the U.S. market. This high-profile case dovetails with broader policy issues between the U.S. and China relating to trade and intellectual property; as such, it attracted attention from the media and from many bipartisan elected officials and trade groups.
  • Successfully defended Sigmapharm Laboratories, LLC in connection with its application for approval of a generic version of the antidepressant vortioxetine.
  • Advised leading biosimilar client regarding litigation strategies for multiple biopharmaceuticals subject to the Biologics Price Competition and Innovation (BPCIA) Act.
  • Aided client FlatWing Pharmaceuticals in demonstrating that 39 claims in 4 patents filed by competitor were unpatentable.
  • Represented TWi Pharmaceuticals, Inc. in a patent infringement case alleging its generic version of Par Pharmaceutical’s Megace ES infringed Alkermes' (formerly Élan) patent for nanocrystal megestrol acetate. After a seven day bench trial, the court entered judgment for TWi in February 2014 finding Alkermes' patent invalid as obvious. Par, Alkermes v. TWi, 2014 WL 694976 (D. Md.)
  • Represented Amerigen Pharmaceuticals, Ltd. in a patent infringement case alleging its generic version of Shire LLC’s Adderalll XR infringed several patents. The case was favorably settled after three days of trial. Shire v. Amerigen (D.N.J.)
  • Represented TWi Pharmaceuticals Inc. in a patent infringement case alleging its generic version of Cephalon’s Amrix infringed several patents. After conducting a seven day bench trial, the court issued an opinion in May 2011 finding that TWi’s product did not infringe any claims of the ’793 and ’372 patents and entered judgment in its favor. Following the decision, TWi filed a motion to deem the case exceptional and for fees. The court granted TWi’s motion and awarded TWi attorneys’ fees. In re Cyclobenzaprine Hydrochloride Extended Release Patent Litigation (D.Del. 2012)
  • Represented Virtus Pharmaceuticals, Inc. in litigation at the International Trade Commission (ITC) alleging Virtus’ potassium chloride products unfairly competed against similar products marketed by Par Pharmaceuticals. The case settled favorably after Virtus filed suit against FDA challenging the agency’s enforcement policies applicable to potassium chloride products. In Matter of: Certain Potassium Chloride Products (ITC); Virtus v. FDA (M.D. Fla)
  • Represented Teh Seng Pharmaceutical Mfg. Co. Ltd. and TWi Pharmaceuticals Inc. in a patent infringement case alleging their generic version of Endo’s Lidoderm transdermal patch infringed several patents. The case was favorably settled on the eve of trial. Endo, Teikoku v. TWi, Teh Seng (D. Del. 2014)
  • Represented TWi Pharmaceuticals, Inc. in a patent infringement case alleging its generic version of Purdue's Intermezzo infringed several patents. After trial appeal, the patents were found invalid as obvious. Purdue Pharmaceuticals v. TWi (D. N.J. 2015)
  • Represented TWi Pharmaceuticals Inc. (and its predecessor Anchen Pharmaceuticals Inc.) in a patent infringement case alleging its generic version of Shire’s Intuniv infringed several patents. The case was favorably settled after the filing of a motion for summary judgment. Shire v. Anchen, TWi (D.Del. 2012)
  • Represented MedPharmex in a patent infringement case regarding its generic version of Merck's animal drug Mometamax. After initial proceedings, the Court entered a judgment of noninfringement in favor of our client.
  • Represented Anchen Pharmaceuticals Inc. (now Par Pharmaceutical) in a patent infringement case involving its generic version of Jazz’s Luvox CR. The case was favorably settled after filing a motion for summary judgment. Elan, Jazz v. Anchen (C.D. Cal. and D. Del. 2010)
  • Represented Anchen Pharmaceuticals (now Par Pharmaceutical)in a patent infringement case alleging its generic version of Biovail’s Wellbutrin XL infringed several patents. The court granted Anchen’s motion for summary judgment finding that Anchen’s product did not infringe any Biovail patent. Biovail also made two attempts to seek an injunction against the Food and Drug Administration (FDA) to prevent approval of Anchen’s Abbreviated New Drug Application (ANDA) product, both of which were denied. Anchen launched its generic product in December 2006. Biovail Labs v. Anchen (C.D. Cal. 2006)
  • Successfully defended pharmaceutical manufacturer in U.S. International Trade Commission (ITC) against competitor's claim that generic drug was marketed unfairly.
  • Aided Sigmapharm Laboratories in arguing for claim construction. Court adopted proposed construction verbatim.
  • Secured victory for TruPharma, LLC in federal court litigation brought by a competitor alleging false advertising and unjust enrichment, among other counts, in connection with the manufacture and sale of a medical cream. Complaint dismissed with prejudice.
  • Forest Labs, et al. v. Teva Pharmaceuticals USA, Inc., et al., 14-cv-00121 (D. Del.). Served as lead trial counsel representing world's largest generic drug company in patent infringement dispute relating to generic company's attempt to market generic version of $2.2 billion blockbuster Alzheimer's drug, Nameda XR, before patent expiration. An analyst attending the trial reported that Jeff's cross-examination of the brand company's main expert witness "drew blood on almost every point." After the trial was over, but before decision, the case settled favorably for the generic company under confidential terms.
  • Purdue v. Teva Pharmaceuticals USA, Inc., 14-cv-02357 (S.D.N.Y.) Part of a team that secured a victory for a large pharmaceutical company in a patent infringement case involving oxycontin. Successfully argued that four of plaintiff's patents lacked novelty or were obvious; fifth patent was ruled invalid for indefiniteness. Client secured favorable settlement.
  • Hoffmann-La Roche v. Teva Pharmaceuticals USA, Inc., 09-cv-5283 (D. N.J.). Lead trial counsel in a Paragraph IV Hatch-Waxman case representing a pharmaceutical company concerning its ANDA for capecitabine (Xeloda®). Challenged the infringement and validity of listed Orange Book patents; case settled on favorable terms on the eve of trial.
  • OSI Pharmaceuticals, Inc., Pfizer, Inc. And Genentech, Inc. v. Teva Pharmaceuticals USA, Inc., et al., 09-cv-00185 (D. Del.). On a team representing a pharmaceutical company against charges of infringement of compound, polymorph and method patents relating to erlotinib (Tarceva®) in a Paragraph IV Hatch-Waxman case. Client was offered a favorable settlement on the first day of trial.
  • Celgene v. Teva Pharmaceuticals USA, Inc., 04-cv-04030 (D. N.J.). Lead trial counsel in a Paragraph IV Hatch-Waxman case over its efforts to introduce a generic version of Focalin® (dexmethylphenidate) into the consumer market. Achieved a successful settlement for the defendant.
  • Astra v. Kremers Urban Development Co. and Schwarz Pharma., 99-cv-08928 (S.D.N.Y.). Part of a team representing Kremers Urban Development Co. and Schwarz Pharma in support of their ANDA seeking permission to launch a generic version of Prilosec® onto the market. The drug was netting around $10 million per day. Achieved a successful decision for clients in multidistrict litigation, finding no infringement, and permitting clients to introduce a generic version of the drug.

Transactions

  • Served as counsel to a Fortune 500 medical device company in connection with the company's strategic investment transactions.
  • Served as counsel to a privately held, North Carolina-based spine medical device company in connection with a merger transaction with a Florida-based, publicly held medical device company.
  • Served as counsel to a United Kingdom public limited company in connection with the company's acquisition of the ear, nose, and throat business of a publicly held, Tennessee medical device company.
  • Served as counsel to a publicly held pharmaceutical company in connection with a merger transaction involving a privately held, New Jersey-based pharmaceutical manufacturer.
  • Served as counsel to a privately held, Minnesota-based orthopedics company in connection with the company's venture and strategic investment transactions.
  • Served as counsel to a privately held, Midwest based medical device AI imaging and diagnostic company in connection with strategic investment and commercial transactions.
  • Advised on creation and design of B2B and B2C business model for national behavioral telehealth technology company. Model was tailored to comply with federal and applicable state legal and regulatory requirements, including telehealth, corporate practice, fee splitting, privacy and security, and corporate formalities.
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News Releases | September 07, 2022
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Ericka Curls Bartling will join Husch Blackwell as a partner in the firm’s San Francisco Bay Area office, and Andrew J. Demetriou will join the firm’s Los Angeles office as senior counsel, bolstering the firm’s capabilities and presence in California.

News Releases | April 01, 2022
Husch Blackwell Adds Two Healthcare Partners to Virtual Office

Husch Blackwell is pleased to announce that Lisa T. Thomas and Bryan Stewart have joined the firm’s Healthcare, Life Sciences & Education industry group as partners.

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Husch Blackwell Lands Leading Litigator Tracy Wolf

Tracy Wolf joins Husch Blackwell’s Dallas office as a partner in its Labor & Employment practice team and Healthcare, Life Sciences & Education business unit.

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The service has been exceptional. Working directly with the attorneys has been great. They give matters their full attention.

Associate general counsel, medical product company